Post-marketing surveillance

Abstract

When a new drug is released for general therapeutic use, little is known about its potential adverse effects. Premarketing clinical trials include small numbers of patients and thus rare adverse effects may not be detected. Their duration is short, when compared with the potential future routine clinical use of the drug, and thus adverse effects due to prolonged exposure are not recognized. High risk groups are usually excluded from premarketing trials, but after marketing they may be exposed to the new drug. In many trials patients treated with drugs other than those tested are also excluded, so that interactions cannot be identified [1,2].

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